BENGAL STACKABLE CAGE SYSTEM

K073649 · Depuy Spine, Inc. · MQP · Jan 25, 2008 · Orthopedic

Device Facts

Record IDK073649
Device NameBENGAL STACKABLE CAGE SYSTEM
ApplicantDepuy Spine, Inc.
Product CodeMQP · Orthopedic
Decision DateJan 25, 2008
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3060
Device ClassClass 2
AttributesTherapeutic

Intended Use

The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™, M-2 ANTERIOR PLATE™, ISOLA®, VSP®, MOSS®MIAMI, TiMX™, MONARCH™, EXPEDIUM™, VIPER™, and PROFILE™).

Device Story

The Bengal Stackable Cage System (VBR Spinal System) is a spinal intervertebral body fixation orthosis used to replace diseased or fractured vertebral bodies in the thoracolumbar spine (T1-L5). The device acts as a structural spacer to restore vertebral height and biomechanical integrity of the spinal column. It is implanted by a surgeon during an anterior decompression procedure. The system is designed to be used in conjunction with supplemental internal fixation, such as titanium plate or rod systems, to stabilize the spine. The device provides mechanical support to the spinal column, potentially benefiting patients by relieving neural compression and restoring spinal stability. The system consists of stackable cages with modified footprints compared to previous versions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional similarity to predicate devices.

Technological Characteristics

Materials: Carbon-fiber reinforced polymer (CFRP), Titanium alloy (ASTM F-136), Tantalum (ASTM 560). Form factor: Stackable cage system for vertebral body replacement. Mechanical fixation device.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumors or fractures; intended to restore vertebral height and achieve anterior decompression of spinal cord/neural tissues; requires use with supplemental internal fixation.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ ี 19 ## IX. 510 (k) Summary | SUBMITTER: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 | JAN 25 2008 | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | CONTACT PERSON: | Frank S. Jurczak | | | DATE PREPARED: | December 21, 2007 | | | CLASSIFICATION NAME: | 21 CFR 888.3060 Implant, Fixation Device<br>Spinal Intervertebral Body Fixation Orthosis Device | | | PROPRIETARY NAME: | Bengal Stackable Cage System | | | PREDICATE DEVICES: | Stackable Cage System (K990148, K001340)<br>Surgical Titanium Mesh System<br>(K003043, K020522)<br>DePuy Acromed VBR System (K031635) | | | INTENDED USE: | The VBR Spinal System is indicated for use in the<br>thoracolumbar spine (i.e., T1 to L5) to replace a diseased<br>vertebral body resected or excised for the treatment of<br>tumors, to achieve anterior decompression of the spinal<br>cord and neural tissues, and to restore the height of a<br>collapsed vertebral body.<br><br>The VBR Spinal System is also indicated for treating<br>fractures of the thoracic and lumbar spine.<br><br>The VBR Spinal Cage System is designed to restore the<br>biomechanical integrity of the anterior, middle and<br>posterior spinal column even in the absence of fusion for a<br>prolonged period.<br><br>The VBR Spinal System is intended for use with<br>supplemental internal fixation. The supplemental internal<br>fixation systems that may be used include titanium plate or<br>rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™,<br>M-2 ANTERIOR PLATE™, ISOLA®, VSP®,<br>MOSS®MIAMI, TiMX™, MONARCH™, EXPEDIUM™,<br>VIPER™, and PROFILE™). | | | MATERIALS: | Carbon-fiber reinforced polymer (CFRP)<br>Titanium alloy conforming to ASTM F-136<br>Tantalum conforming with ASTM 560 | | {1}------------------------------------------------ The additional size cages are identical to the previously DESCRIPTION: cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, rendered in black lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in public health and human services. JAN 25 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DuPuy Spine, Inc. % Mr. Frank S. Jurczak 325 Paramount Drive Raynham, MA 02780 Re: K073649 Trade/Device Name: VBR Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 21, 2007 Received: December 26, 2007 Dear Mr. Jurczak: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 -- Mr. Frank S. Jurczak This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Mark M. Mikkelsen Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## IV. Indications for Use 510(k) Number (if known): Device Name: VBR Spinal System Indications For Use: The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusio of a prolonged period. The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium platton: rnd Systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™, M-2 ANTERIOR PLATE™, ISOLA®, VSP®, MOSS®MIAMI, TiMX™, MONARCH™, EXPEDIUM™, VIPER™, and PROFILE™). (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109) Mark A. Milkers (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%